Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions (BPAP)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Phoenix Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mark Hostetler, Phoenix Children's Hospital
ClinicalTrials.gov Identifier:
NCT01229384
First received: October 26, 2010
Last updated: June 8, 2012
Last verified: June 2012
  Purpose

Hypothesis: That administration of nebulized therapy for bronchiolitis when using positive airway pressure is superior to standard mask ventilation in reducing hospital admissions.

Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by a variety of different viruses. It is the most common LRTI in children under 24 months old. Multiple studies have documented variation in treatment, hospitalization rates, and length of hospital stay for bronchiolitis, suggesting a lack of consensus and an opportunity to improve care for this common disorder.

Research to determine optimal delivery methods of respiratory medications that may augment oxygenation by decreasing atelectasis (Lung cell collapse) and increasing oxygen saturation have not been done. Currently bronchodilators are delivered through a passive process, inhaled as they are nebulized (made from liquid into gas) into a face mask. This study will evaluate whether using a newly developed positive pressure nebulization device that uses pressure to expand lung cells and, hypothetically, deliver the medication better, improves oxygenation by reducing atelectasis (lung cell collapse) to decrease hospitalization in infants with moderate to severe bronchiolitis.

Positive pressure nebulization is a relatively new adaptation of a previously existing modality, and is already currently in use here at PCH.


Condition Intervention
Bronchiolitis
Device: Positive Airway Pressure nebulization
Device: Standard passive nebulization of respiratory medications

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Standard Versus Positive Pressure Nebulization in Infants With Bronchiolitis to Reduce Hospital Admissions

Further study details as provided by Phoenix Children's Hospital:

Primary Outcome Measures:
  • Hospitalization Rates [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Will measure rate of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.


Secondary Outcome Measures:
  • Change in bronchiolitis Score [ Time Frame: day of presentation ] [ Designated as safety issue: No ]
    Will measure change in bronchiolitis score by repiratory therapy of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

  • Change in Oxygen Saturation [ Time Frame: Day of presentation ] [ Designated as safety issue: No ]
    Will measure change in oxygen saturation of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

  • Intensive Care Unit Admission Rate [ Time Frame: day of presentation ] [ Designated as safety issue: No ]
    Will measure rate of hospitalization in the intensive care unit of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

  • Length of Stay [ Time Frame: To be determined ] [ Designated as safety issue: No ]
    Will measure length of hospitalization of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.

  • Unscheduled Return to the Emergency Department [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Will measure rate of unscheduled return to the ED of children comparing those treated with positive airway pressure nebulization and those with standard nebulization.


Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Positive Airway Pressure Nebulization
Will administer nebulized medications using Positive Airway Pressure Nebulization
Device: Positive Airway Pressure nebulization
Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
Active Comparator: Standard Nebulization
Current standard of administering nebulized medications without positive airway pressure
Device: Standard passive nebulization of respiratory medications
Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.

  Eligibility

Ages Eligible for Study:   2 Months to 24 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants 2-24 months with moderate to severe bronchiolitis

Exclusion Criteria:

  • Those outside the age range of 2-24 months, or less than postconceptual age of 48weeks for premature infants
  • Those with comorbid conditions such as cyanotic heart disease, home oxygen use, tracheostomy use, or other serious medical conditions.
  • Those with history of apnea
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01229384

Contacts
Contact: Zebulon J Timmons, MD 402-203-9303 ztimmons@phoenixchildrens.com
Contact: Mark Hostetler, MD 602-546-1910 mhostetler@phoenixchildrens.com

Locations
United States, Arizona
Phoenix Children's Hospital Recruiting
Phoenix, Arizona, United States, 85016
Contact: Lara Hale, BA    602-546-1910    lhale@phoenixchildrens.com   
Contact: David Bank, MD    602-546-1910    dbank@phoenixchildrens.com   
Principal Investigator: Zebulon J Timmons, BA, MD         
Sub-Investigator: Mark Hostetler, MD         
Sub-Investigator: David Bank, MD         
Sub-Investigator: Dawn Barcellona, MD         
Sub-Investigator: Blake Bulloch, MD         
Sub-Investigator: Tom McConahay, MD         
Sub-Investigator: Rustin Morse, MD         
Sub-Investigator: Theresa Murdock, MD         
Sub-Investigator: Anthony Pickett, MD         
Sub-Investigator: Tamara Pottker, MD         
Sub-Investigator: Chris Ramsook, MD         
Sub-Investigator: Lalitha Ravi, MD         
Sub-Investigator: Karen Scharlatt, DO         
Sub-Investigator: Kopal Seth, MD         
Sub-Investigator: Robert Yniguez, MD         
Sub-Investigator: Stephanie Zimmerman, MD         
Sub-Investigator: Ming Chien, MD         
Sub-Investigator: Angelique Ferayorni, DO         
Sub-Investigator: Amanda Kasem, MD         
Sub-Investigator: William Schneider, DO         
Sub-Investigator: Karem Collindres-Duque, DO         
Sub-Investigator: Amanda Queen, PA         
Sub-Investigator: Lisa Keller, NP         
Sub-Investigator: Jessica Snow, NP         
Sub-Investigator: Carol Thrall, NP         
Sub-Investigator: Becky Brown, NP         
Sub-Investigator: Scharon Schaeffer, NP         
Sub-Investigator: Candy Schmitz, NP         
Sponsors and Collaborators
Phoenix Children's Hospital
Investigators
Principal Investigator: Zebulon J Timmons, MD Phoenix Children's Hospital
Study Director: Mark Hostetler, MD Phoenix Children's Hospital
  More Information

No publications provided

Responsible Party: Mark Hostetler, Principal Investigator, Phoenix Children's Hospital
ClinicalTrials.gov Identifier: NCT01229384     History of Changes
Other Study ID Numbers: BronchPAP
Study First Received: October 26, 2010
Last Updated: June 8, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on August 21, 2014